Center Quality Manager I: QA & Compliance Lead

Octapharma Plasma, Inc.; Kansas City (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Formal training

Health insurance

Health savings account

Flexible spending account

Tuition Reimbursement

Employee assistance program

Wellness program

401k retirement plan

Paid time off

Company paid holidays

Personal time

Job summary

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to uphold compliance with FDA/EMA standards, lead QA activities, and oversee donor safety at the plasma center level. The role emphasizes audits, CAPAs, and staff training within a fast-growing company that values quality and continuous improvement.

The position requires a B.S. degree preferred and at least one year in a QA role, with a focus on QMS and quality control processes.

Qualifications

• B.S. degree preferred.
• One year of experience in a Quality Assurance role is required.
• Experience with quality management systems (QMS) and quality control processes is preferred.

Responsibilities

• Operate independent of plasma center Operations to ensure compliance with regulations and industry standards.
• Maintain current knowledge of regulations affecting plasma collection and donor safety.
• Report critical incidents and negative trends to Operations team and Regional Quality Director.
• Collaborate with Operations to ensure product quality and donor safety.
• Monitor quality performance indicators, deviations, CAPAs, and complaints.
• Oversee QC processes including donor screening, plasma collection, storage, and shipping.
• Perform final QA review and release for shipments and documents.
• Lead audits and inspections and develop audit responses.
• Maintain audit records and follow up on findings.
• Train Quality backup staff and Plasma Center Quality Manager I.
• Develop and deliver training on GMP, SOPs, and regulatory compliance.
• Carry out proficiency assessments and ensure SOP-driven SOP compliance.
• Maintain calibration documentation and perform root-cause analysis for issues.
• Promote continuous improvement in quality systems and monitor changes.
• Lead monthly Quality Assurance meetings and communicate minutes to staff.
• Assist in selecting and onboarding Quality Backup staff.

Skills

Quality Assurance

Regulatory compliance

GMP knowledge

Education

B.S. degree preferred

Job description

Octapharma Plasma, Inc. is seeking a Center Quality Manager I to uphold compliance with FDA/EMA standards, lead QA activities, and oversee donor safety at the plasma center level. The role emphasizes audits, CAPAs, and staff training within a fast-growing company that values quality and continuous improvement.

The position requires a B.S. degree preferred and at least one year in a QA role, with a focus on QMS and quality control processes.